UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the symptom by a pharmacist performing continuously inhalational instruction for the Cough variant asthma patients who newly introduced Symbicort Tubuhaler.
Acronym	Examination of the symptom by a pharmacist performing continuously inhalational instruction for the Cough variant asthma patients who newly introduced Symbicort Tubuhaler.
Scientific Title	Examination of the symptom by a pharmacist performing continuously inhalational instruction for the Cough variant asthma patients who newly introduced Symbicort Tubuhaler.
Scientific Title:Acronym	Examination of the symptom by a pharmacist performing continuously inhalational instruction for the Cough variant asthma patients who newly introduced Symbicort Tubuhaler.
Region	Japan

Condition
Condition	Cough variant asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We think about how much affects the symptom by continuing the inhalational instruction by the pharmacist.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of Cough Visual Analogue Scale (VAS) six months after initial instruction.
Key secondary outcomes	Technique of using inhalation device

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Continuously inhalational instruction by the pharmacist. Four times of intervention (in the first time and the first month, the second month, the fourth month).
Interventions/Control_2	Only as for the initial inhalational instruction by the pharmacist.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient with Cough variant asthma using Symbicort Turbuhaler for the first time.
Key exclusion criteria	1. The patients who remarkably have low understanding degree. 2. The patients with the sequelae that the movement of the finger is confined to remarkably. 3. In addition, the patients whom a study person in charge judged to be inadequate as subjects.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Akihiro Goto
Organization	Juntendo university Shizuoka hospital
Division name	Drug department
Zip code
Address	1129, Nagaoka, Izunokuni-shi, Shizuoka
TEL	0559483111
Email	a-gotou@juntendo.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Akihiro Goto
Organization	Juntendo university Shizuoka hospital
Division name	Drug department
Zip code
Address	1129, Nagaoka, Izunokuni-shi, Shizuoka
TEL	0559483111
Homepage URL
Email	a-gotou@juntendo.ac.jp

Sponsor
Institute	Juntendo university Shizuoka hospital, Drug department
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 10 Month 11 Day
Date of IRB	2017 Year 10 Month 11 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2018 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 26 Day
Last modified on	2019 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033942